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The drug, Keytruda (pembrolizumab), was tested on more than 600 patients who had melanoma that had spread throughout their bodies. Because so many of the patients in the early testing showed significant long-lasting responses, the study was continued and the FDA granted the drug “breakthrough therapy” status, allowing it to be fast-tracked for approval.

The largest Phase 1 study in the history of oncology, the research was conducted at UCLA and 11 other sites in the U.S., Europe and Australia.

Keytruda, formerly known as MK-3475, is an antibody that targets a protein called PD-1 that is expressed by immune cells. The protein puts the immune system’s brakes on, keeping its T cells from recognizing and attacking cancer cells, said Dr. Antoni Ribas, the study’s principal investigator and a professor of medicine in the division of hematology-oncology at the David Geffen School of Medicine at UCLA.

For many years, when using immunotherapy to fight cancer, doctors’ strategy has been to bolster the immune system so it could kill the cancer cells. But the approach had limited success because PD-1 prevented the immune system from becoming active enough to attack the cancer.

Keytruda, in effect, cuts the brake lines, freeing up the immune system to attack the cancer.

“This drug is a game changer, a very significant advance in the treatment of melanoma,” said Ribas, who also is a researcher at UCLA’s Jonsson Comprehensive Cancer Center. “For patients who have not responded to prior therapies, this drug now provides a very real chance to shrink their tumors and the hope of a lasting response to treatment.”

Judith Gasson, senior associate dean for research at the David Geffen School of Medicine at UCLA and director of the Jonsson Cancer Center, said researchers have long hoped to develop an effective and lasting immunotherapy to fight cancer.

“We have long believed that harnessing the power of our own immune systems would dramatically alter cancer treatment,” she said. “Based upon work conducted over the past two decades, we are beginning to see the clinical benefits of this research in some of the most challenging cancers.”

Generally, about 1 in 10 patients responded to previous immunotherapy drugs. Some of those who responded, however, exhibited long-lived benefits, which sustained scientists’ interest in the method as an effective mechanism to fight cancer.

The response and duration rates for Keytruda were much greater than for previous drugs, Ribas said. In the new study, 72 percent of patients responded to the drug, meaning that their tumors shrank to some degree. Overall, 34 percent of patients showed an objective response, meaning that their tumors shrank by more than 30 percent, and did not re-grow.

Ribas said Keytruda has the potential to be used to treat other cancers that the immune system can recognize, including cancers of the lung, bladder, head and neck.

Survivors’ stories Kathy Thomas, 59, of Torrance, California, was diagnosed in September 2011 with melanoma that had spread to her liver and was invading her left breast. She underwent several therapies that did not work, and she was weakening fast.

“I lost weight. I threw up nearly every day,” Thomas said. “My hair was thinning. I just had no strength at all. I was so sick I had to use a wheelchair.”

Thomas met with Ribas in 2012 but was skeptical about enrolling in a trial to test an experimental therapy. She soon overcame her hesitation.

Since enrolling in the study, Thomas’ tumors have shrunk. She regained her strength and her appetite. She’s out of her wheelchair and walking normally again. She said she has experienced no side effects from the therapy, and she travels monthly to San Francisco to visit her grandson.

Tom Stutz, 74, of Sherman Oaks, California, was diagnosed in June 2011 with melanoma that had spread to his lung, liver and other parts of his body. He didn’t see how he could survive, but he decided to enroll in the clinical trial of Keytruda anyway.

“I wasn’t eating. I was on oxygen. I couldn’t walk,” he said. “When I went into the hospital at the end of May [2012], I didn’t think I was coming out.”

Gradually, though, Stutz started feeling better. Today, he’s no longer on oxygen and walks several miles every day.

“It’s the little things that make me happy now,” Stutz said. “I’m very appreciative that I get to get up in the morning, go into my backyard and see my garden. I’m able to be with my children and grandchildren, go on vacations with them. I was close to the end of the road, as far as you can get to the edge of the cliff, and I was pulled back by this treatment.”

Melanoma incidence rates have been increasing for at least 30 years. An estimated 76,100 new cases of melanoma will be diagnosed in the U.S. in 2014, and nearly 10,000 Americans will die from the disease this year. While melanoma accounts for less than 2 percent of all skin cancer cases, it is responsible for the vast majority of skin cancer deaths, according to the American Cancer Society.

UCLA researchers found that men who aren’t well educated about their disease have a much more difficult time making treatment decisions, called decisional conflict, a challenge that could negatively impact the quality of their care and their long-term outcomes.

The study should serve as a wake-up call for physicians, who can use the findings to target men less likely to know a lot about their prostate cancer and educate them prior to their appointments so they’re more comfortable making treatment decisions, said study first author Dr. Alan Kaplan, a resident physician in the UCLA Department of Urology.

“For prostate cancer, there is no one right answer when it comes to treatment. It comes down to the right answer for each specific patient, and that is heavily dependent on their own personal preferences,” Kaplan said. “Men in general, and specifically economically disadvantaged men, have a hard time deciding what their preferences are, how they feel about any possible complications and what the future after treatment might be like. If you don’t know anything about your disease, you’ll have a really tough time making a decision.”

The findings from the one-year study appear in the early online edition of the peer-reviewed journal Cancer.

The research team surveyed 70 men at a Veterans Administration clinic who were newly diagnosed with localized prostate cancer and had enrolled in a randomized trial testing a novel shared decision-making tool. They collected baseline demographic and clinical such as age, race, education, co-existing medical conditions, relationship status, urinary and sexual dysfunction and their prostate cancer knowledge.

UCLA researchers talked one-on-one with the men after they had received their cancer diagnosis, but before they consulted with a physician. Median age of the men in the study was 63 years, 49% were African American and 70% reported an annual income of less than $30,000.

Kaplan said the team found that a low level of prostate cancer knowledge was associated with increased decisional conflict and higher uncertainty about what treatment to choose. Low levels of prostate cancer knowledge also were associated with lower perceived effectiveness — meaning the less they knew about their cancer, the less confidence they had that the treatment would be effective.

“Knowledge about prostate cancer is an identifiable target. Interventions designed to increase a patient’s comprehension of prostate cancer and its treatments may greatly reduce decisional conflict,” Kaplan said, adding that further study is needed to better characterize this relationship and identify effective targeted interventions.

“If you get shot in the gut, there aren’t many options. You go into the operating room to get fixed up,” he said. “With prostate cancer, there are lots of options and not all are right for everybody.”

Men with prostate cancer might need to decide between surgery versus radiation or opting for active surveillance, in which patients are monitored closely for changes in the progression of their cancer and are tested at regular intervals. Prostate cancers can also be treated implantable radioactive seeds or tumors may be burned or frozen as treatment.

Another benefit to reducing decisional conflict is that patients who feel comfortable with their decision may regret their decisions less down the line, Kaplan said. They’re less likely to sue their doctors and generally experience better outcomes.

“In a way, it’s like buying a car. You prepare, you read reports, do your homework,” Kaplan said. “If something goes wrong with the car, you feel OK because you knew what you were getting into. When patients take ownership of the decision-making process, their outcomes are better.”

Kaplan said economically disadvantaged men may be having more difficulty because they may not have as much experience negotiating the healthcare system and are less confident when communicating with doctors.

“Doctors, we know intuitively, should spend more time with their patients, especially when they’re making an important decision,” he said. “But all of us are challenged with the numbers of patients we must see in a day. If you know beforehand that a patient has a poor knowledge about his cancer, that’s someone you need to spend more time with.”

Doctors may also want to provide these patients with educational information before their consultation so they can begin to increase their prostate cancer knowledge, Kaplan said.

Prostate cancer is the most frequently diagnosed cancer in men aside from skin cancer. An estimated 233,000 new cases of prostate cancer will occur in the United States in 2014. Of those, nearly 30,000 men will die.